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Summary of Accomplishments

Highlights

Read about the New Chemicals Program in OPPT's previous accomplishment reports.

Since the TSCA Inventory was established in 1979, EPA has reviewed almost 39,000 new chemical submissions (called Premanufacture Notices or PMNs) and an additional 15,000 PMN exemption notices. Here is a breakdown of the submissions and notices.

 

New Chemicals Program Activities Through September 30, 2014

Type of Submission Number Submitted Since 1979 FY 2014 FY 2014
Premanufacturing Notices
38,973
659
638
Test Marketing Exemption Applications (TMEA)
851
4
24
Low Volume Exemptions (LVE)
11,907
392
368
Low Release/Low Exposure Exemptions (LoRex)
88
3
5
Polymer Exemptions*
2,530
Total**
54,349
1,058
1,035


Regulatory Action on PMNs Number Issued
FY 2014
FY 2013
Section 5(e) consent orders
1,651
23
28
SNURs following section 5(e), Consent Orders - subset
(1,049)
(105)
(159)
Non-5(e) SNURs following PMN review
932
53
40
PMNs withdrawn in face of action
1,962
55
66
Voluntary testing actions
300+
Total cases regulated
4,845
131
134

* Since May 30, 1995, individual reporting for exempt polymers has not been required; reporting is now on a yearly basis on January 31 of the following year.
** Total does not include Exemption modifications
+ Approximate

Approximately 10% of the 39,000 total PMN submissions have resulted in various restrictions, additional testing requirements, and notices withdrawn in the face of regulation. For exemption notices, EPA can grant or deny the notice, with or without certain conditions of use specified in the notice, to which the submitter is legally bound.

Section 5(e) Consent Orders:

More than 1,600 of all new chemicals submitted as PMNs have been subject to consent orders under TSCA section 5(e). Such "section 5(e) consent orders" serve to limit the production, processing, distribution in commerce, use, and disposal of new chemical substances that raise health or environmental concerns, pending receipt of required information.

Significant New Use Rules (SNURs):

A subset of 1,049 of the above-mentioned consent orders have associated with them a SNUR, issued by EPA under TSCA section 5(a)(2). In general, these SNURs mimic the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order. For such chemical substances, persons are required to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the substance for the use designated as significant. The required SNUN provides EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs. In addition to these 1,049 SNURs, an additional 932 new chemical substances were regulated by EPA with SNURs which require notice to EPA for potential new uses of the chemical (other than those reviewed as part of the PMN) that may pose unreasonable risks.

Voluntary Testing Actions (TSCA section 5(e) Ban Pending Testing):

In more than 300 cases, PMN submitters voluntarily agreed to suspend the notice review period and conduct hazard or environmental fate testing in response to EPA's request.

Withdrawals:

In more than 1,900 cases, companies have withdrawn PMNs in the face of EPA concerns and likely regulatory requirements.

 


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